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In the middle of 2021, COVID-19 continued to exist. In some European countries, there was a variant COVID-19. According to the feedback from experts, the mutant COVID-19 had a strong transfection.

In addition to actively promoting vaccination, European countries have also actively promoted and supported the policy of checking new infections of the COVID-19 virus. Bfarm is the abbreviation of the Federal Institute of drugs and medical devices in Germany and it provides a list of the antigen tests for the direct pathogen detection of the coronavirus SARS-CoV-2, which are intended by the manufacturer for professional use (“rapid tests”) and, to the knowledge of the BfArM, bear a CE marking.

The KaiBiLiTM COVID-19 Antigen Rapid Test Device gets the permits in BfArM.

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The KaiBiLiTM COVID-19 Antigen Rapid Test Device is an immunochromatographic assay for the qualitative detection of 2019 Novel Coronavirus antigens. This assay is intended for rapid screening in a laboratory. The COVID-19 Antigen Rapid Test Device has two letters on the surface of the test device indicating test line (T) and control line (C). The test line and control line in the result window is not visible before applying any samples. The control line is a reference line that indicates the test is performing properly. The control line must appear every time when the test is performed. If SARS-CoV-2 is present in the sample, the test line would appear. The highly selective antibodies to SARS-CoV-2 are used as capture and detector in the assay. These antibodies can detect SARS-CoV-2 antigens directly, with high accuracy.

Target population and user for the test is suspected patients and the general population. The target antigen is 2019 Novel Coronavirus nucleocapsid protein antigens. Specimen types of nasal and nasopharyngeal specimens can be used for the test.


Post time: Aug-05-2021